Reetika Borate

 Reetika Borate PERSONAL INFORMATION +1 - - SKILL SET - Proficient in working with Microsoft Office Suite - Knowledge of safety databases (eg. AWARE, ARISg) HIGHLIGHTS - Excellent verbal and written communication skills - Good organizational skills with the ability to work under pressure and meet deadlines under stringent time constraints - Detail oriented - Excellent analytical and problem solving skills LANGUAGES English – Proficient French- Basic CAREER SUMMARY Nov’18 – Present Apr’15 – Oct’18 Apr’14 – Mar’15 Apr’13 – Mar’14 Senior Pharmacovigilance Specialist Parexel International, India Pharmacovigilance Specialist Parexel International, India Pharmacovigilance Analyst Quantum Solutions, India Pharmacovigilance Scientist, Quantum Solutions, India EXPERIENCE Management of Individual Case Safety Reports (ICSRs) Coding of AEs and SAEs in clinical databses Data entry of ICSRs in the safety database, including determining the expectedness of adverse events, writing case summaries, assessing causalities if required and writing company comment if required, Data validation i.e. cross checking against source documentation Familiar with E2B guidelines for submission of reports to regulatory agencies. Maintaining a good working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including ICH guidelines on safety and efficacy, FDA guidelines, New EU PV legislation Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Well versed with MedDRA, WHODD terminology. Interacting with appropriate client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies Performing PV quality check of the translated forms/reports and providing feedback to linguists Checking overall medical cohesiveness and consistency of the translated text Carrying out translation of adverse event forms/reports from French to English Mentoring PV Quality Scientists EDUCATION Aug’06 – Dec’ 11 M. Tech. (Integrated) Biotechnology Amity University, India